At the end of last year, ChemCon was particularly active in the area of regulatory documentation. New Drug Master Files (DMFs) were successfully prepared and submitted for chromium(III) chloride hexahydrate and sodium molybdate dihydrate.
Both substances are manufactured at ChemCon under GMP conditions and are used in various pharmaceutical and diagnostic applications. With the preparation of these DMFs, ChemCon further expands its regulatory support for these products and establishes a solid basis for their use in regulated development and approval projects.
DMFs are a key element in the approval of pharmaceutical active ingredients and excipients. They contain detailed information on manufacturing, quality, analytical methods and control strategies and allow customers to reference this data in their own regulatory submissions without having to disclose sensitive manufacturing information. This helps to streamline regulatory processes and reduce coordination efforts within approval procedures.
With the new DMFs for chromium(III) chloride hexahydrate and sodium molybdate dihydrate, ChemCon strengthens the regulatory robustness of these products and supports customers in reliably implementing projects with increased quality and documentation requirements.
